inforMED
MalfunctionFBO

CYSTO-URETHRO-FIBERSCOPE

Received Aug 28, 2019 · Event occurred Jan 15, 2019

Report 8939302 · MDR key 8939302

Device

Generic name

Cystourethroscope

Model number

11272C1

Product problems

  • Break
  • Contamination

Patient

25550 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PRE-PROCEDURE DIAGNOSIS: LEFT STAGHORN CALCULUS. PROCEDURE NAME: ELECTIVE LEFT PERCUTANEOUS NEPHROLITHOTOMY, LEFT NEPHROSTOMY TUBE INSERTION, LEFT NEPHROSTOGRAM. PROCEDURE FINDINGS: LEFT RENAL CALCULUS EXTRACTED SUCCESSFULLY UTILIZING FLEXIBLE NEPHROSCOPE, LEFT NEPHROSTOGRAM DEMONSTRATES NO EXTRAVASATION. CONDITION: PATIENT TOLERATED PROCEDURE. DISPOSITION: TRANSFERRED TO: PACU. SURGEON OBSERVED BLACK PARTICLE WHEN DOING PROCEDURE - REALIZED IT CAME FROM END OF FLEXIBLE CYSTOSCOPE - WAS ABLE TO RETRIEVE IT AND THE PIECE MATCHED THE END OF THE CYSTOSCOPE - MODEL#11272 C1 - MANUFACTURER IS STORZ. INSTRUMENT HAD BROKEN PIECES OF COATING ON TIP OF SCOPE. THE SCRUB TECH, SURGEON AND RN IN CASE EXAMINED THE SCOPE TIP AND DECIDED THAT ALL PIECES HAD BEEN RETRIEVED. PATIENT STABLE AND DISCHARGED HOME. SCOPE GOING FOR REPAIR.